OMEGA-3-ACID ETHYL ESTERS capsule, liquid filled

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)

Доступна с:

PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of TG-lowering drug the

Обзор продуктов:

Omega-3-acid ethyl esters capsules USP are supplied as 1 gram oblong, clear, soft gel capsules filled with slightly yellow to yellow liquid and imprinted with "PC25" in white ink. They are supplied in bottles of 120 (NDC 24658-350-12) Store at 20° C to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children. Protect from light.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEGA-3-ACID ETHYL
ESTERS CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR OMEGA-3-ACID
ETHYL ESTERS CAPSULES.
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules are a combination of ethyl esters
of omega 3 fatty acids, principally
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA),, indicated
as an adjunct to diet to reduce
triglyceride (TG) levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. (1)
Limitations of Use:
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 1 gram (3)
CONTRAINDICATIONS
Omega-3-acid ethyl esters capsules are contraindicated in patients
with known hypersensitivity (e.g.,
anaphylactic reaction) to omega-3-acid ethyl esters or any of its
components. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (incidence >3% and greater than
placebo) were eructation,
dyspepsia, and taste perversion. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT [PURACAP LABORATORIES,
LLC DBA BLU
PHARMACEUTICALS AT 1-888-374-2791] OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid
ethyl esters and an
anticoagulant or other drug affecting coagulation (e.g., anti-platelet
agents) should be monitored
periodically. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2023
The effect of omega-3-acid ethyl esters capsules on the risk for
pancreatitis has not been
determined. (1)
The effect of omega-3-acid ethyl esters capsules on cardiovascular
mortality and morbidity has not
been determined. (1)
The daily dose of omega-3-acid ethyl esters capsules is 4 grams per
day taken as a single 4-gram
dose (4 capsules) or as two 2-gram doses (2 c